Rosuvastatin belongs to a class of medications commonly called "statins" which are medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent atherosclerosis (hardening of blood vessels) and lower risk of heart attacks and other circulation problems. Recent studies in the general non-HIV infected population have shown that the beneficial effect of statins in preventing circulation problems is larger than would be expected from lowering of LDL-cholesterol alone. It has been suggested that the additional beneficial effect of statins may be due to the anti-inflammatory effect of statins.

The risk of heart attacks and other circulation problems may be high in HIV infected individuals. This may be due to the inflammatory stress effects of HIV. The main purpose of the study is to see if rosuvastatin will have a beneficial effect on the circulatory system in HIV infected individuals even in those who do not have high LDL cholesterol levels. Therefore, in HIV-infected individuals with normal or low LDL cholesterol levels but with evidence of low HDL cholesterol levels which may be a sign of low grade inflammation, the study will look at whether 3 months of rosuvastatin will lead to improvement in brachial artery flow-mediated dilatation (FMD), a marker of early atherosclerosis (hardening of the blood vessels).

On stable antiretroviral therapy for > 6 months with no plans to change therapy during the treatment phase of the study

Plasma HIV RNA < 50 copies/mL

Karnofsky performance score > 70 within 30 days prior to study entry

Ability to understand and sign informed consent

Following laboratory values obtained within 30 days prior to randomization:

Absolute neutrophil count (ANC) > 750/mm3

Hemoglobin >/= 8.0 g/dL

Platelets >/= 50,000/mm3

ALT (SGPT) and AST (SGOT) < 2.5 x ULN

Fasting glucose < 126 mg/dL

TSH < 3.0 mIU/L

HDL-C < 50 mg/dL in men, < 55 mg/dL in women

Direct LDL-C </= 130 mg/dL

Calculated creatinine clearance > 50 mL/min

Willing to be treated with rosuvastatin or be on an observational arm for a minimum of 3 months

Female subject must not participate in a conception process (active attempt to become pregnant) or be post-menopausal. If participating in sexual activity that could lead to pregnancy, the subject must use contraception while receiving study medication and 30 days after stopping the medication

Any acute illness within 30 days prior to study entry that, in the opinion of the site investigator, would interfere with participation in the study.

Use of lopinavir/ritonavir (Kaletra) as part of current HIV antiretroviral regimen

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986999

Locations

United States, Hawaii

Hawaii Center for AIDS

Honolulu, Hawaii, United States, 96813

Sponsors and Collaborators

University of Hawaii

Investigators

Principal Investigator:

Cecilia Shikuma, MD

Hawaii Center for AIDS, John A. Burns School of Medicine, University of Hawaii